Image Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Image Systems, Inc. makes
Image Systems, Inc. manufactures medical imaging systems, including the SCIVIEW System (models SC1250 and PIXIE Imaging Software), a diagnostic imaging device, and the STATVIEW, a portable ultrasound imaging system. The company also produces the INFRAVIEW/INFRASION-Telethermographic System, which captures thermal images for diagnostic purposes.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance registry. These products are listed in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Statview Ref K913755
Regimes: 510(k) Registry: 510(k)Infraview/Infrasion-Telethermographic System Ref K844771
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Image Systems, Inc. have in the registry?
The registry currently lists 3 devices for Image Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Image Systems, Inc.'s devices?
Among its 3 most recently registered devices, Image Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Image Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Image Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Image Systems, Inc. in the registry?
The most recently registered devices listed for Image Systems, Inc. include SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF, STATVIEW and INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM.